Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants
NCT ID: NCT04922645
Last Updated: 2022-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
214 participants
INTERVENTIONAL
2021-06-29
2022-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ferric citrate (commercially available, Auryxia)
Ferric citrate, (commercially available Auryxia), supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.
Ferric Citrate 1 gram Oral Tablet
Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD).
Standard of care phosphate lowering therapy
Non-Auryxia phosphate-lowering therapy administered as standard of care.
Standard of care phosphate-lowering therapy
Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals.
Interventions
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Ferric Citrate 1 gram Oral Tablet
Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD).
Standard of care phosphate-lowering therapy
Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of end-stage kidney disease and receiving maintenance dialysis (in-center, home hemodialysis or peritoneal dialysis) for greater or equal to 12 weeks prior to randomization.
3. Most recent transferrin saturation less than or equal to 50 percent
4. Most recent serum phosphate is greater or equal to 3.0 milligrams per deciliter
5. Receiving treatment for greater or equal to 8 weeks prior to screening with non-Auryxia phosphate lowering therapy. No requirement for stable dosing within this time frame.
6. Receiving treatment for greater or equal to 8 weeks prior to screening with erythropoiesis-stimulating agent (any dose, any type). No requirement for stable dosing within this time frame.
7. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Exclusion Criteria
2. Hypersensitivity reaction to previous oral iron therapy.
3. History of hemochromatosis or other iron overload syndrome.
4. Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
5. Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal or recreational marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the Investigator).
6. Limited life expectancy (less than 6 months), (in the opinion of the Investigator).
7. Scheduled organ transplant and participants on the kidney transplant wait-list who are expected to receive a transplant within 6 months of screening. Being active on transplant list is not an exclusion. Previous kidney transplant is not an exclusion.
8. Unable to comply with study requirements or in the opinion of the Investigator not clinically stable to participate in the study.
9. Females who are known to be pregnant or are breast-feeding during Screening or are planning to become pregnant and breastfeeding during the study period.
10. Evidence of clinically active infection at the time of Screening.
11. Use of an investigational medication or participation in an investigational study within 30 days prior to Screening.
18 Years
ALL
No
Sponsors
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Akebia Therapeutics Inc.
UNKNOWN
USRC Kidney Research
NETWORK
Responsible Party
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Locations
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US Renal Care - Dimond
Anchorage, Alaska, United States
US Renal Care - Mesa
Mesa, Arizona, United States
US Renal Care - Pine Bluff
Pine Bluff, Arkansas, United States
US Renal Care - Northridge Roscoe
Granada Hills, California, United States
US Renal Care - Dalton
Dalton, Georgia, United States
US Renal Care - Major Health
Shelbyville, Indiana, United States
US Renal Care - Red Rocks
Gallup, New Mexico, United States
US Renal Care - North Dallas
Dallas, Texas, United States
Dallas Renal Group
Dallas, Texas, United States
US Renal Care - Houston Street
San Antonio, Texas, United States
US Renal Care - Palo Alto
San Antonio, Texas, United States
US Renal Care - Pleasanton Rd.
San Antonio, Texas, United States
US Renal Care - Westover Hills
San Antonio, Texas, United States
Countries
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References
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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Other Identifiers
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USRC-2021-001
Identifier Type: -
Identifier Source: org_study_id
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